Quality Assurance Specialist

Vor 5 Tagen

Köln, Nordrhein-Westfalen, Deutschland Walker Cole International Vollzeit

Walker Cole International is seeking a highly skilled Quality Assurance Specialist to join our team in the pharmaceutical industry. As a key member of our quality functions, you will play a crucial role in ensuring the company's products meet current Good Manufacturing Practice (GMP) regulations and regulatory standards.

Key Responsibilities:

  • Develop and Maintain Quality Management System (QMS): Ensure the QMS is aligned with current GMP regulations and regulatory standards.
  • Ensure Compliance with GxP Standards: Oversee all manufacturing, testing, and release activities to ensure they are conducted in accordance with current GxP standards.
  • Batch Release and Quality Control: Conduct Qualified Person's batch release responsibilities and ensure the quality of our products.
  • Internal and External Audits: Manage and conduct both internal and external audits to ensure compliance with regulatory requirements.

Requirements:

  • Professional Degree as Pharmacist: Hold a professional degree as a pharmacist and be a Qualified Person according to the German Medicines Act (§14 AMG).
  • Regulatory Knowledge: Possess strong knowledge of cGMP, GDP, FDA, and EU guidelines.
  • Leadership and Communication Skills: Demonstrate strong leadership, communication, and organizational skills with a pragmatic quality mindset.

Walker Cole International is a leading provider of pharmaceutical services, and we are committed to delivering high-quality products that meet the needs of our customers. If you are a motivated and experienced Quality Assurance Specialist looking for a new challenge, we encourage you to apply for this exciting opportunity.

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